Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

Parker & Waichman, LLP announced that it has filed suit against Ortho-McNeil Pharmaceutical, Inc., a division of Johnson and Johnson Inc., on behalf of the estate of a 26-year-old woman. The decedent died from an acute pulmonary embolism after using the Ortho
Evra birth control patch from November 26, 2002 to July 8, 2003. The suit was
filed in the United States District Court for the Eastern District of Michigan.Prime
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